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Delayed Umbilical Cord Clamping - C-section Pilot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229162
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date July 22, 2014
First Posted Date September 1, 2014
Last Update Posted Date May 30, 2017
Study Start Date October 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2014)
maternal estimated blood loss (EBL) [ Time Frame: at delivery (approximately 1 hour duration) ]
Excessive EBL will be assessed by three measures
  1. clinical assessment by anesthesia/obstetrics after surgery noting amount of blood suctioned and on drapes, to include weighing of drapes at > 800 mL
  2. difference between pre- and post-op hemoglobin levels of > 20% more than that in baseline data
  3. need for transfusion,
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02229162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 27, 2014)
  • neonatal hypothermia [ Time Frame: at admission (within 30 minutes of birth) ]
    moderate or severe neonatal hypothermia (36.2 rectal or less)
  • newborn hemoglobin concentration and hematocrit [ Time Frame: first day of life (0-24 h of age) ]
    mean hemoglobin concentration and incidence of polycythemia (hct >65 with symptoms, 70 without symptoms) and anemia (hgb <14.5 g/dL)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 27, 2014)
  • phototherapy [ Time Frame: < 14 days of age ]
    phototherapy for hyperbilirubinemia without evidence hemolysis during birth hospitalization or readmission during first 14 d of life
  • Neonatal intensive care (NICU) 'observation' or admission [ Time Frame: birth hospitalization (first 72 h of age approximately) ]
    NICU 'observation' during transition or admission will be measured and reason for admission. respiratory symptoms are most of interest, but historical controls will only have data yes/no so we will look at overall nicu admissions also.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Delayed Umbilical Cord Clamping - C-section Pilot
Official Title Delayed Umbilical Cord Clamping For Term Infants: A Pilot Safety Trial During Cesarean Deliveries
Brief Summary This is a pilot study of delayed cord clamping (DCC) at progressively longer intervals (90 to 120 seconds) during elective cesarean deliveries of term infants. The investigators hypothesize that the pilot trial of DCC in cesarean sections will demonstrate safety of this procedure for mothers and babies.
Detailed Description

Despite expert recommendations to delay clamping the cord for at least 2 minutes, early cord clamping remains a common obstetrical practice. The World Health Organization has noted that data on cesarean deliveries are more limited, particularly with respect to long-term effects in infants. Recently, the American College of Obstetrics and Gynecology also noted in a committee statement that " the ideal time for clamping of the umbilical cord in cesarean section vs. vaginal birth is a particularly important area for future research".

The objective of this study is to conduct a pilot trial of delayed cord clamping during cesarean deliveries to determine if progressively longer intervals of cord clamping are feasible and not related to poorer maternal and neonatal outcomes as compared to outcomes from historical controls. We will offer study entry for women planning elective cesarean delivery to collect prospective data on progressively longer intervals, analyzing outcomes for each time interval to ensure they are clinically acceptable, prior to extending the interval another 30 s. We anticipate approximately 20 women at each interval (90 and 120 sec) and will perform hemoglobin analysis on the infants specifically for this study. If intraoperative blood loss is clinically deemed excessive, or mother or baby are unstable, the cord will be clamped.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population pregnant women 18 years of age or older that plan on having an elective Cesarean delivery of a term singleton infant.
Condition Cesarean Sections
Intervention Not Provided
Study Groups/Cohorts
  • 90 seconds DCC
    the initial 15-20 subjects (15 enrolled subjects who complete study) will have cord clamped at 90 seconds. Then data will be analyzed and evaluated by DSMB
  • Two minutes DCC
    If Data Safety Monitoring Board (DSMB) concurs, DCC will then be practiced for 2 minutes for second group, which is the minimum amount of time recommended to be defined as DCC.
Publications * Chantry CJ, Blanton A, Taché V, Finta L, Tancredi D. Delayed cord clamping during elective cesarean deliveries: results of a pilot safety trial. Matern Health Neonatol Perinatol. 2018 Jul 4;4:16. doi: 10.1186/s40748-018-0083-3. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 29, 2016)
41
Original Estimated Enrollment
 (submitted: August 27, 2014)
40
Actual Study Completion Date November 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:Subjects that are pregnant (women 18 years of age and older) and scheduled for an elective C-section at ≥ 37 weeks gestation will be eligible for the study.

Exclusion Criteria:

Pregnant women that do not plan on having a C-section and individuals that are not pregnant. Pregnant women that are medically unstable, have poorly controlled diabetes mellitus, multiple gestations, anomalous fetuses and/or severe intrauterine growth retardation will be excluded. Adults unable to consent will not be included

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02229162
Other Study ID Numbers 400656-4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor University of California, Davis
Collaborators Not Provided
Investigators
Principal Investigator: Caroline Chantry, MD University of California, Davis
PRS Account University of California, Davis
Verification Date February 2016